Click on the dot next to the best answer for each question.

1. It should be clearly stated if there are no benefits to a study.
      True
      False

2. Beneficence means that each person has the right to decide not to be in a study.
      True
      False

3. Justice in terms of human research means, attempting at all times to distribute the risks and benefits to the human subjects fairly and without bias.
      True
      False

4. Adverse events should be reported to the IRB
      immediately.
      within one week.
      within 2 weeks.
      within one month.

5. A participant who is not of legal age can consent to be in a study.
      True
      False

6. Autonomy means that participants should be protected from harm.
      True
      False

7. The purpose of continuing review is to determine if the risks and benefits:
      are understood by the participants.
      are accurately outlined in the current consent document.
      are permissible to the participants.
      reflect the experience of the subjects.

8. ____________signify developments that might require a revised consent form.
      Unexpected complications
      Adverse events
      Breeches of confidentiality
      All of the above

9. When listing risks, you do not need to list "soft" risks such as embarrassment.
      True
      False

10. You will know the terms of continued review when you receive approval from the IRB.
      True
      False

11. The consent document should be presented to the participant when it is most convenient for the investigators.
      True
      False

12. Risks and benefits are better understood by the researcher after the research has begun.
      True
      False

13. A consent document should generally be written to a/an ________ grade reading level.
      third
      fifth
      eighth
      tenth

14. The participant can __________ withdraw from the study without penalty.
      never
      occasionally
      usually
      always

15. ____________ is/are not important factor(s) when asking and answering questions.
      Open-ended questions
      Patience and encouragement
      Directive questions
      Preparation

16. Research projects conducted at other sites should be reviewed by the JMU IRB as well as the other institution's IRB.
      True
      False

17. The ________________ relationship is not a potentially troublesome one during participant selection.
      doctor/patient
      teacher/student
      parent/child
      employer/employee

18. No further review is required once the IRB has reviewed a project.
      True
      False

19. Researchers with financial interests in the research must inform their participants.
      True
      False

20. The James Madison University's IRB reviews only federally funded research.
      True
      False

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